Lessons Learned from PrEP Trial Cancellations

Between August 2004 and February 2005, the HIV prevention world was rocked by the suspension and cancellation of two pre-exposure prophylaxis (PrEP) trials in Cambodia and Cameroon. To the considerable surprise of researchers, advocates and donors, these HIV prevention trials became embroiled in escalating controversies and sparked protests by activists speaking on behalf of the communities where trial participants were being recruited. The activists not only raised questions about how the research was being conducted, but also challenged the fundamental ethics and underlying motives of the research.

Just this week, my colleagues at the Global Campaign for Microbicides released two in-depth case studies relating the events that led to these trial cancellations and extracting the lessons they provide for current and future research:

• Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site by Elizabeth McGrory, Andrea Irvin and Lori Heise
• Preventing Prevention Trial Failures: A Case Study and Lessons for Future Trials from the 2004 Tenofovir Trial in Cambodia by Anna Forbes and Sanushka Muldaliar

Acknowledging that no single version of the events constitutes the “real story”, the case studies are built from extensive interviews with researchers, policymakers and other government officials, donors, NGO staff, and advocates to reconstruct often incompatible accounts of what eventually led to government intervention that halted the research. The case studies capture the political context and backdrop against which the controversies arose and the underlying and unaddressed conflicts that led to the costly collapse of two Phase 3 trials.

These reports are important and exciting reading for anyone interested in sound science, human rights, gender equality and communication across enormous cultural, social, and economic disparities. The HIV prevention field has made substantial progress since 2005 in forging mechanisms to be transparent and build trust between trial communities and researchers. Still, much remains to be done and the potential for conflict remains.

As the first PrEP trials move toward completion this year, these case studies offer a timely look at what we have learned and what pressing challenges remain unaddressed.

The two case studies are available on-line at http://www.global-campaign.org/.


UPDATE: Dr. Free-Ride over at the blog Adventures in Ethics and Science is going to be hosting a virtual journal club on these two case-studies. Join in the fun here.